Assessment of Efficacy of Zoledronic Acid in the Treatment of Bone Marrow Edema Syndrome

NCT01348269 | Completed Phase 3 Results

• 1 other identifier: CZOL446HDE38T
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

The primary aim is to test the reduction of bone marrow edema syndrome after a singular intravenous treatment with Zoledronic Acid within 6 weeks compared to placebo. The volume of the edema is defined as biometric data measured by the use of MRT before and six weeks after treatment. The hypothesis has to be checked whether Zoledronic Acid is efficient in the treatment of painful bone marrow edema. A statistically significant reduction of the edema in the MRT is considered as evidence for efficacy.

Conditions

Bone Marrow Edema

Keywords

bone marrow edema; Aclasta

Outcome Measures

Primary Outcomes (1)

• Reduction of the Edema Area

  The volume of the edema in cm³ is defined as biometric data measured by the use of MRI before and six weeks after treatment. Edema volume at screening was set to 100%. Edema volume six weeks after study drug administration was provdied as percentage reduction compared to the value at screening

  Week 6 after administration of a single intravenous dose of zoledronic acid (5 mg)

Secondary Outcomes (12)

• Reduction of Pain (VAS)

  Assessment at week 3

• Reduction of Pain

  Assessment at week 6

• Quality of Life (Qualeffo-41 Questionnaire)

  Assessment at week 3

• Quality of Life (Qualeffo-41 Questionnaire)

  Assessment at week 6

• Subjective Estimation of Medical Condition (PDI)

  Assessment at week 3

Study Arms (2)

Aclasta

ACTIVE COMPARATOR

Drug: Aclasta

NaCl Solution

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Aclasta DRUG

1 x intravenous non-current drip (infusion)

Aclasta

Placebo DRUG

NaCl Solution

NaCl Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men: age over ≥ 18 years or women: age over ≥ 18 years with finished reproductivity according to the following definition:
• ≥ 12 month persistent natural (spontaneous) amenorrhoea (women aged \<50: additionally: FSH \>40MIE/ml and estrogen deficiency of \<30pg/ml or a negative estrogen test)
• status post hysterectomy and / or bilateral oophorectomy
• finished reproduction planning
• secure diagnosis of bone marrow edema using MRT
• current osteologic basic laboratory values (≤ 4 weeks before V2) according to DVO criteria
• presence of an personally signed informed consent for the participation in the study

You may not qualify if:

• \- subchondral bone loss or already occurred cartilage damage due to the bone marrow edema
• reactive bone marrow edema with advanced arthrotic changes in the adjacent joint (grade III and IV according to Kellgren and Lawrence)
• patients with edematous changes in bone marrow due to the diagnosis of M. Sudeck / algodystrophy / Complex Regional Pain Syndrome (CRPS)
• patients with known hypo- and hyperparathyroidism, osteogenesis imperfecta, osteomalacia, M. Paget or another systemic skeletal diseases, except osteoporosis
• patients with bone necrosis in the painful skeletal region
• patients with infectious process at the affected bone or the adjacent joint and adjacent soft parts, respectively
• patients with diagnosed or assumed rheumatoid arthritis, Lupus erythematodes, collagenosis or vasculitides
• patients with advanced renal insufficiency (GFR according to Cockcroft
• / Gault ≤ 40 ml/min/KO)
• patients with malignant diseases with osseous manifestation in anamnesis/history
• status post malignant basic/primary disease with large dosed chemotherapy
• current or massive dose therapy completed before less than 6 weeks (\>7.5mg prednisolon equivalent) with glucocorticoids
• patients with a malignant tumor disease within the past 5 years, independent from the affected organ system and independent from the implemented treatment, the presence of a relapse or metastatic invasion, except basal cell carcinoma and squamous-cell carcinoma of the skin Current treatment due to uveitis
• vague/ambiguous hyper- or hypocalcemia, hyper- or hypophosphatemia
• etiological vague/ambiguous AP-increase

Sponsors & Collaborators

• Wuerzburg University Hospital: lead
• Crolll Gmbh: collaborator
• University of Wuerzburg: collaborator

Study Sites (2)

Orthopedic Center for Musculoskeletal Research, Orthopedic Department, University of Wuerzburg

Würzburg, Bavaria, 97074, Germany

Location

Department of trauma, hand, reconstructive and plastic, University of Wuerzburg

Würzburg, Bavaria, 97080, Germany

Location

MeSH Terms

Interventions

Zoledronic Acid

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Lothar Seefried
• Organization: University Hospital Wuerzburg - Department of Orthopaedics (Clinical Study Unit)

l-seefried.klh@uni-wuerzburg.de

+499318033590

Study Officials

• Rainer Meffert, Prof. Dr.

  Department of trauma, hand, reconstructive and plastic, University of Wuerzburg

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Lothar Seefried

Study Record Dates

• First Submitted: May 2, 2011
• First Posted: May 5, 2011
• Study Start: May 1, 2011
• Primary Completion: August 26, 2015
• Study Completion: August 26, 2015
• Last Updated: August 13, 2024
• Results First Posted: August 13, 2024

Record last verified: 2024-08

Locations

DE (2)